Protein Formulation Development

At HTL Biosolutions, Inc., we offer both consulting and contract research services on protein characterizations, stability testings and formulation development.  Our company founder, Dr. Tiansheng Li, has nearly 13 years of working experience at Amgen Inc.  Before leaving Amgen Inc., Dr. Li held the position of Preclinical Director at the Department of Pharmaceutics and Drug Delivery, and he has successfully led the completion of a number of protein formulation projects for clinical trials and the CMC sections for IND and BLA filings.  At the invitation of ACS, Dr. Li has also taught training courses on protein formulation development at ACS Prospective Conferences in the past few years.

 

Key formulation services

 

On site training course on protein formulation development

Pre-formulation study

Formulation protocol design for any particular protein project

Analytical method development to analyze protein formulations

Protein-Delivery device compatibility study

Shelf-life study of protein formulation

Accelerated stability study 

 

Services offered: 

 

Pre-formulation screening study

At HTL Biosolutions, Inc., we offer services focused on pre-formulation screening studies inculding pH screening, buffer screening, excipient screening, surfactant screening and preservative screening studies.  Our company founder and scientists have extensive experiences in designing appropriate screening studies to save you time and effort.  Novel combinations of appropriate screening studies shall also add useful data for potential patent applications.

 

Protein formulation optimization

At HTL Biosolutions, Inc., we offer technical services to optimize formulation parameters such as pH, salt concentration, stabilizer concentration, surfactant concentration etc.  The optimization of formulation parameters is essential to establish manufacturing specification parameters.  

 

Device compatibility study

At HTL Biosolutions, Inc., we offer customized services related to product-device compatibility study such as pre-filled syringe, auto-injector and syringe pump studies.  Protein therapeutics are normally susceptible to surface denaturation, and there are in-depth regulatory requirements on stability studies covering protein-device (primary container) compatibility.   We offer services focused on protein stability design and analysis, in combination with delivery devices.   

 

© 2019 by HTL Biosolutions, Inc.